Form FDA 483 · Issued 2026-02-27
Gascó Industrial Corporation — FDA Form 483 Analysis
FEI: 3010222586 · Sector: Pharmaceuticals & Sterile/OTC Drugs (OTC Drug Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to Gascó Industrial Corporation (FEI 3010222586) on 2026-02-27 following an inspection of its otc drug manufacturer operations in Puerto Rico. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.188(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Accurate reproduction
Inspector Observation Language: "The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed]. Specifically, observed during inspection of Gascó Industrial Corporation on 2026-02-27."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #2 · 21 CFR 211.198(b)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
REPEAT CITATION AT FACILITY
Written record of complaint to include findings, follow-up
Inspector Observation Language: "Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up]. Specifically, observed during inspection of Gascó Industrial Corporation on 2026-02-27."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #3 · 21 CFR 211.42(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Adequate space lacking to prevent mix-ups and contamination
Inspector Observation Language: "The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination. Specifically, observed during inspection of Gascó Industrial Corporation on 2026-02-27."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #4 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Lack of/inadequate, environmental monitoring
Inspector Observation Language: "[Lack of] [Inadequate] routine environmental monitoring in the [ISO 5 area] [classified areas]. Specifically, observed during inspection of Gascó Industrial Corporation on 2026-02-27."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #5 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Backup file not maintained
Inspector Observation Language: "Failure to maintain a backup file of data entered into the computer or related system. Specifically, observed during inspection of Gascó Industrial Corporation on 2026-02-27."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.